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HAT 1 Scanning Kit
EUDAMEDClass I (EU MDR)
Ref PKA-15Model HAT 1 Scanbody: PS-01~07; HAT 1 Lab Analog: PA-01~02; HAT 1 Screwdriver: PD-S-01~02, PD-A-01~07; HAT 1 Scanning Kit: PKA-01~27Ref PKA-13Ref PKA-24Ref PKA-09Ref PKA-10Ref PKA-08Ref PKA-03Ref PKA-19Ref PKA-22Ref PKA-26Ref PKA-16Ref PKA-05Ref PKA-04Ref PKA-12Ref PKA-23Ref PKA-32
Identity
- Trade Name
- HAT 1 Scanning Kit EUDAMED
- Device Name
- Dental implant accessories EUDAMED
- Model / Reference
- HAT 1 Scanbody: PS-01~07; HAT 1 Lab Analog: PA-01~02; HAT 1 Screwdriver: PD-S-01~02, PD-A-01~07; HAT 1 Scanning Kit: PKA-01~27 EUDAMEDPKA-15 EUDAMEDPKA-13 EUDAMEDPKA-24 EUDAMEDPKA-09 EUDAMEDPKA-10 EUDAMEDPKA-08 EUDAMEDPKA-03 EUDAMEDPKA-19 EUDAMEDPKA-22 EUDAMEDPKA-26 EUDAMEDPKA-16 EUDAMEDPKA-05 EUDAMEDPKA-04 EUDAMEDPKA-12 EUDAMEDPKA-23 EUDAMEDPKA-32 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975136231151 EUDAMED06975136231137 EUDAMED06975136231243 EUDAMED06975136231090 EUDAMED06975136231106 EUDAMED06975136231083 EUDAMED06975136231038 EUDAMED06975136231199 EUDAMED06975136231229 EUDAMED06975136231267 EUDAMED06975136231168 EUDAMED06975136231052 EUDAMED06975136231045 EUDAMED06975136231120 EUDAMED06975136231236 EUDAMED06975136231328 EUDAMED
- Basic UDI-DI
- 697513623PTHAT1RS EUDAMED
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
HAT 1 Scanning Kit by Ziyang Freqty Medical Equipment Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697513623PTHAT1RS | Class I | Active |
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Manufacturer
- Manufacturer
- Ziyang Freqty Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000019421
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (16)
- EUDAMED addbbdcf-ba56-4352-a8f5-fc090e8b4c7e 61 fields · synced Oct 7, 2026
- EUDAMED 9a195fec-8db3-49bf-99a7-dc04eda6e59e 61 fields · synced May 17, 2026
- EUDAMED 2a3390bb-9dd6-4285-a1a0-3652ef744452 61 fields · synced May 17, 2026
- EUDAMED d1dc4962-6198-4535-814a-8ef956cb1527 61 fields · synced May 17, 2026
- EUDAMED 55142e2a-2ee8-45de-8b10-c0abaf292d64 61 fields · synced May 17, 2026
- EUDAMED bd6f8001-0a1e-4c5d-8f4a-f9909c00d6c1 61 fields · synced May 17, 2026
- EUDAMED 759083ee-457c-4e4f-8cd5-74828c759f75 61 fields · synced May 17, 2026
- EUDAMED 6f6883ba-c307-491f-83da-6bf2fb1a783d 61 fields · synced May 18, 2026
- EUDAMED de0378ca-71e6-4354-8beb-4e85393c53fc 61 fields · synced May 18, 2026
- EUDAMED 99e8f96b-b34e-4c0c-aed9-f9b0909c7ff1 61 fields · synced May 18, 2026
- EUDAMED f09d0c44-a8b5-4d53-ba95-150ff53c355e 61 fields · synced May 18, 2026
- EUDAMED 3679201b-7487-490a-bfe0-f8b511b8b012 61 fields · synced May 18, 2026
- EUDAMED ddb1966b-be32-40d6-956d-8df690380e42 61 fields · synced May 19, 2026
- EUDAMED bead013f-0b1e-4c73-8b0c-06859eb20ea6 61 fields · synced May 19, 2026
- EUDAMED 3e38d488-02d3-474b-a2b4-deee52ea7788 61 fields · synced May 19, 2026
- EUDAMED 9793dbbc-d3ac-4c10-a3d5-5909a2abbc71 61 fields · synced Jul 8, 2026